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FDA 510(k)

EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS

K-Number: K913395 · 1992-05-20

ApplicantPro-Tech, Inc.
Decision Date1992-05-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tech, Inc.. It received FDA 510(k) clearance on 1992-05-20 under 510(k) number K913395. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS?

EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS is a medical device that received FDA 510(k) clearance on 1992-05-20. The listed applicant is Pro-Tech, Inc.. The 510(k) number is K913395.

When did EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS receive FDA 510(k) clearance?

EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS received FDA 510(k) clearance on 1992-05-20, under 510(k) number K913395.

Who is the listed applicant for EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS?

The FDA 510(k) record lists Pro-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS?

The FDA product code for EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS is BZG.

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Other records listing Pro-Tech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K940013BODY POSITION INDICATOR, MODEL BPI1K940015SNORING MICROPHONE, SM1K940014PLM SENSOR, MODEL PLM1K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACEK923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORK913396CANNULA STYLE THERMOCOUPLES

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Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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